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目的:考察干扰醋酸氯己定溶液微生物限度检查的因素并建立了化学药品醋酸氯己定溶液微生物限度检查方法试验。方法:参照中国药典2005年版二部附录微生物限度检查方法试验。结果:采用常规法对细菌、霉菌及酵母菌和控制菌进行验证。该药品均对枯草芽孢杆菌,金黄色葡萄球菌,大场埃希菌及铜绿假单胞菌有较强的抑菌作用,故可采用常规法进行霉菌及酵母菌检查;可采用离心薄膜过滤法对细菌进行检查;可采用薄膜过滤加培养基稀释法对控制菌进行微生物限度检查的质量控制。结论:所建立的微生物限度检查方法可用于醋酸氯己定溶液微生物限度检查,消除本品抑菌活性对试验的干扰.
OBJECTIVE: To investigate the factors that interfere with the microbial limit test of chlorhexidine acetate solution and to establish a method for testing the limits of microorganisms of the chemical chlorhexidine acetate solution. Methods: According to the Chinese Pharmacopoeia 2005 edition two appendix microbial limit test method test. Results: Bacteria, molds, yeasts and control bacteria were verified by routine methods. The drugs are Bacillus subtilis, Staphylococcus aureus, Escherichia coli and Escherichia coli Pseudomonas aeruginosa has a strong bacteriostatic effect, it can be used for routine testing of mold and yeast; centrifuge membrane filtration can be used Check the bacteria; thin film filtration plus medium dilution method can be used to control microbial quality control of the limit test. Conclusion: The established method of microbial limit test can be used to limit the microbial limit of chlorhexidine acetate solution to eliminate the antibacterial activity of this product interfere with the test.